348 results
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Sources: EU EUDAMED, US FDA
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PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
FDA Enforcement
Class III
·Terminated·DNA Genotek Inc.·September 30, 2020
PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.
FDA Recall
Terminated
·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code PPM·June 24, 2020
Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·September 29, 2021
Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKO·August 5, 2021
5 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 5 Hole Locking 1st Tarsometatarsal Plate... REF 70-0007-S... LOT W58115".
FDA Recall
Terminated
·Acumed LLC·Product code HWC·February 14, 2008
4 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 4 Hole Locking 1st Tarsometatarsal Plate... REF 70-0008-S... LOT W58116".
FDA Recall
Terminated
·Acumed LLC·Product code HWC·February 14, 2008
Left Locking Dorsal 1st MTP Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking Dorsal 1st MTP Fusion Plate... REF 70-0012-S... LOT W58120".
FDA Recall
Terminated
·Acumed LLC·Product code HWC·February 14, 2008
Left Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 1st MTP Revision Fusion Plate... REF 70-0018-S... LOT W58121".
FDA Recall
Terminated
·Acumed LLC·Product code HWC·February 14, 2008
Right Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking 1st MTP Revision Fusion Plate... REF 70-0019-S... LOT W58122".
FDA Recall
Terminated
·Acumed LLC·Product code HWC·February 14, 2008
Left Locking 2st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 2st MTP/MPJ Combo Fusion Plate... REF 70-0036-S... LOT W58123".
FDA Recall
Terminated
·Acumed LLC·Product code HWC·February 14, 2008
Right Locking 1st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking 1st MTP/MPJ Combo Fusion Plate... REF 70-0037-S... LOT W58148".
FDA Recall
Terminated
·Acumed LLC·Product code HWC·February 14, 2008
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
FDA Enforcement
Class II
·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·December 24, 2014
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·August 8, 2012
Portex 1st Response Adult Manual Resuscitators Ref: 8500P
FDA Recall
Terminated
·Sims Portex Inc.·Product code BTM·November 15, 2002
Portex 1st Response Adult Manual Resuscitators Ref: 8503P
FDA Recall
Terminated
·Sims Portex Inc.·Product code BTM·November 15, 2002
Portex 1st Response Adult Manual Resuscitators Ref: 8506P
FDA Recall
Terminated
·Sims Portex Inc.·Product code BTM·November 15, 2002
Integra Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HRS·February 9, 2012
Tarsys 1st Generation Seating System - an optional accessory for the Powered Wheelchairs.
FDA Recall
Terminated
·Invacare Corp·Product code ITI·March 10, 2003
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
FDA Enforcement
Class I
·Terminated·Monteris Medical Corp·March 28, 2018
LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. (2) DRAPE UNDERBUTTOCK WITH POUCH (4) TOWELS ABSORBENT 15" X 20" ( 1) FEEDING TUBE 8FR, 15" LONG ( 1) BEANNIES BABY ( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK ( 1) UMBILICAL CORD CLAMP ST. ( 1) RECEIVING BLANKET 100% COTTON ( 1) TOWELS CLOTH HUCK (BLUE) (2) LEGGINGS W/7" CUFF 30" X 42" ( 1) BABY BLANKET 30 X 30 POLY ABS IMPERV. ( 1) BOWL PLASTIC 80oz ( 1) LID FOR BOWL 80oz CLEAR (20) GAUZE SPONGE 4" X 4" 16PLY (2) PAD OBSTETRICAL X-LARGE ST. ( 1) PACKING VAGINAL XRD 4 X 36 8PLY ( 1) TABLE COVER REINFORCED 50" X 90" ( 1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1 ) NEEDLE HYPODERMIC 21G X 1% ST. (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) PVP SCRUB 8" STICK SPONGES ST. ( 1) EAR ULCER SYRINGE 2oz. ( 1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (2) WRAPPER 30" X 30" ( 1) PVP PAINT 8" STICK SPONGE ST. (2) GLOVE SURG DERMA PRENE #7 % PF (1) TIME OUT BEACON NON WOVEN ST. (1) VACUTAINER GREEN NAHEP 10ML EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014